CHAPTER 95 - DANGEROUS DRUGS ACT: SUBSIDIARY LEGISLATION
INDEX TO SUBSIDIARY LEGISLATION
Dangerous Drugs (Part III) (Application) Notice
Dangerous Drugs (Section 10) (Exemption) Notice
Dangerous Drugs (Section 13) (Exemption) Notice
Dangerous Drugs (Modification of Schedule) Order
[Section 6]
[Currency mentioned in this regulation should be re-denominated as stipulated under S 4 of Re-denomination Act, 2012, read with S 29 of Bank of Zambia Act, 1996.]
Arrangement of Regulations
Regulation
PART I
PRELIMINARY
1. Short title
2. Interpretation
PART II
CONTROL OF RAW OPIUM, ETC.
3. Application
4. Supply, procuring, and advertising of drugs
5. Possession of drugs
6. General authority for certain classes of persons to possess and supply drugs
7. Cultivation of plants
8. Clearing of plants from land by owner or occupier
9. Keeping of register
PART III
CONTROL OF SUBSTANCES IN PART I OF THE SCHEDULE TO THE ACT
10. Application
11. Manufacture of drugs
12. Supply, procuring, and advertising of drugs and preparations
13. Possession of drugs and preparations
14. General authority for certain classes of persons to possess and supply drugs and preparations
15. Special provisions in respect of certain public officers, etc.
16. Special provisions in respect of midwives
17. Special provisions in respect of operators of aircraft
18. General authority for authorised sellers of poisons to manufacture preparations and to retail drugs and preparations
19. Form of prescription
20. Provisions as to supply on prescription
21. Report of cases to Permanent Secretary
22. Treatment of drug addicts
23. Markings of packets and bottles
24. Production of order in writing to supplier
25. Keeping of register
PART IV
GENERAL
26. Definition of “drug”
27. Definition of “possession”
28. Supply otherwise than on prescription
29. Withdrawal of authority
30. Consignment between places outside Zambia
31. Revocation or amendment of license or group authority
32. Requirements as to registers
33. Preservation of documents
34. Exemption of police officers and carriers
35. Exemption of certain classes of agents
36. Requirements in respect of cessation of practice, etc.
37. Construction of license or authority
38. Movement license
39. Form of application for license
40. Revocation of GN 59 of 1956 and savings
[Regulations by the Minister]
Act 13 of 1994,
SI 128 of 1971,
SI 50 of 1976,
SI 65 of 1993.
PART I
PRELIMINARY
These Regulations may be cited as the Dangerous Drugs Regulations.
In these Regulations, unless the context otherwise requires—
“authorised as a member of a group” means authorised by virtue of being a member of a class in respect of which the Permanent Secretary has granted an authority under and for the purpose of regulation 4, 5, 12 or 13 which is in force;
“group authority” means such an authority so granted, and “his group authority”, in relation to a person who is a member of such a class, means the authority so granted to that class;
“authorised seller of poisons” means an authorised seller of poisons within the meaning of the Pharmacy and Poisons Ordinance;
“dental surgeon” means a person registered as a dental surgeon under the Medical and Allied Professions Act, 1965;
“generally authorised” in relation to any person, means authorised by, as the case may be, regulation 6, 11, 14, 16, 17 or 18 by virtue of being a member of a class specified in that regulation, or of being a person of a description so specified, and “general authority” means the authority possessed by a person as aforesaid;
“licensed” means duly licensed by a license issued by the Permanent Secretary to the person named therein, or, as the case may be, in respect of premises named therein, under and for the purposes of regulation 4, 5, 7, 11, 12, 13, 15 or 30, and “license ” and “licensed premises” shall be construed accordingly;
“medical practitioner” means a person registered as a medical practitioner under the Medical and Allied Professions Act, 1965;
“midwife” means a person registered as a midwife under the Medical and Allied Professions Act 1965, or any written law amending or replacing that Act, which provides for registration of midwives;
“nurse” means a person registered as a nurse under the Medical and Allied Professions Act, 1965, or any written law amending or replacing that Act, which provides for registration of nurses;
“Permanent Secretary” means the Permanent Secretary responsible for the Department of the Government for the time being administering the Dangerous Drugs Act, 1967;
“pharmacist” means a person registered as a pharmacist under the Medical and Allied Professions Act, 1965;
“Pharmacy Act book” means either of the books required to be kept by sub-section (2) of section 21 and sub-section (3) of section 24 of the Pharmacy and Poisons Act.
“prescription” means a prescription for a single individual given by a medical practitioner for the purposes of medical treatment, by a dental surgeon for the purposes of dental treatment, or by a veterinary surgeon for the purposes of animal treatment;
“register” means a bound book and does not include any form of loose leaf register or card index;
“registered premises” means premises registered in terms of the Pharmacy and Poisons Act;
“retail business” means the business of retailing, dispensing, or compounding drugs carried on at a shop;
“retail dealer” means a person who carries on a retail business;
“veterinary surgeon” means a person registered as a veterinary surgeon under the Veterinary Surgeons Act;
“wholesale dealer” means any person who carries on the business of selling drugs to persons who buy to sell again.
PART II
CONTROL OF RAW OPIUM, ETC.
This Part of these Regulations shall apply to any drug, resin or preparation, other than poppy straw and extract or tincture of cannabis, to which Part I of the Act applies, and hereafter in this Part the expression “drug” means any such drug, resin or preparation as aforesaid.
4. Supply, procuring, and advertising, of drugs
(1) A person shall not supply, procure, offer to supply or procure, to or for any person, including himself, whether in Zambia or elsewhere, or advertise for sale a drug unless he is generally authorised, or, under this regulation, licensed or authorised as a member of a group so to do, nor otherwise than in accordance with the provisions of these Regulations, and, in the case of a person licensed or authorised as a member of a group, with the terms and conditions of his license or group authority.
(2) A person shall not supply, procure, or offer to supply or procure a drug to, or for, any person in Zambia unless that person is generally authorised, or, under regulation 5, licensed or authorised as a member of a group to be in possession of the drug and the drug is to be supplied or procured in accordance with the provisions of these Regulations, and, in the case of a person licensed or authorised as a member of a group, with the terms and conditions of his license or group authority.
A person shall not be in possession of a drug unless he is generally so authorised or, under this regulation, so licensed or authorised as a member of a group, nor otherwise than in accordance with the provisions of these Regulations and, in the case of a person licensed or authorised as a member of a group with the terms and conditions of his license or group authority.
6. General authority for certain classes of persons to possess and supply drugs
(1) Subject to the provisions of these Regulations, a person who is a member of any of the following classes, that is to say—
(a) medical practitioners;
(b) veterinary surgeons;
(c) authorised sellers of poisons;
(d) registered pharmacists employed or engaged at a hospital, clinic, dispensary, like institution administered by the Government, or by a local authority, in any other hospital, clinic, dispensary or like institution approved by the Minister, or in any Government medical store;
(e) a person in charge of a laboratory used for the purpose of research or instruction and attached to—
(i) the University of Zambia or other educational institution approved by the Minister;
(ii) any hospital referred to in paragraph (d);
(f) a Government analyst;
(g) persons duly appointed inspectors under the Act,
shall be authorised so far as may be necessary for the practice or exercise of his profession, function, or employment, and in his capacity as a member of his said class, to be in possession of, and to supply, drugs.
(2) Every drug in the actual custody of a person authorised by virtue of this regulation to be in possession thereof, shall, except when the necessities of the practice of the profession, function, or employment, by virtue of which that person is authorised as aforesaid, otherwise require, be kept in a locked receptacle which can be opened only by him or some other person authorised by virtue of this regulation to be in possession of the drug.
(1) No person who is not a person licensed under this regulation shall cultivate any plant from which a drug is derived.
(2) No person licensed under this regulation shall cultivate any plant from which a drug is derived otherwise than in accordance with the terms and conditions of his license .
8. Clearing of plants from land by owner or occupier
(1) Every owner or occupier of land shall clear or cause to be cleared from his land any plant from which a drug is derived, which is found to be growing wild or which is being cultivated in contravention of the provisions of these Regulations.
(2) The owner or occupier of land who has cleared or caused to be cleared from his land any plants from which a drug is derived shall destroy the plants so cleared by fire.
Every person generally authorised, licensed, or authorised as a member of a group, to supply any drugs shall comply with the following provisions, that is to say—
(a) he shall, in accordance with the provisions of this regulation and regulation 32, keep a register and enter therein, in chronological sequence in the form specified in the Second Schedule to these Regulations, true particulars with respect to every quantity of any drug obtained by him, and with respect to every quantity of any drug supplied by him whether to persons within or to persons outside Zambia;
(b) he shall use a separate register or separate part of the register with respect to each of the following classes of drugs, that is to say—
(i) raw opium;
(ii) coca leaves;
(iii) cannabis and cannabis resin and all preparations (other than extract or tincture of cannabis) of which cannabis resin forms the base.
PART III
CONTROL OF SUBSTANCES SPECIFIED IN PART I OF THE SCHEDULE TO THE ACT
(1) This Part of these Regulations shall apply to any substance for the time being specified in Part I of the Schedule to the Act.
(2) In the following provisions of this Part the expression “drug” means any substance to which this Part applies other than a preparation as defined for the purpose of this Part in sub-regulation (3).
(3) In this Part the expression “preparation” means any preparation, admixture, extract or other substance, containing any proportion of a substance to which this Part applies.
A person shall not manufacture, or carry on any process in the manufacture of, a drug—
(a) unless he is generally authorised, or licensed under this regulation, so to do:
Provided that no person shall be licensed under this regulation with respect to diamorphine;
(b) except on premises on which he is permitted by his general authority so to do, or on premises licensed for the purpose under this regulation;
(c) otherwise than in accordance with the provisions of these Regulations, and, in the case of a person licensed, with the terms and conditions of his license .
12. Supply, procuring, and advertising of drugs and preparations
(1) A person shall not supply, procure, or offer to supply or procure, to or for any person, including himself, whether in Zambia or elsewhere, or advertise for sale a drug or preparation, unless he is generally authorised, or, under this regulation, licensed or authorised as a member of a group so to do, nor otherwise than in accordance with the provisions of these Regulations, and, in the case of a person licensed or authorised as a member of a group, with the terms and conditions of his license or group authority.
(2) A person shall not supply, procure, or offer to supply or procure a drug or preparation to, or for, any person in Zambia, unless that person is generally authorised, or, under regulation 13, licensed or authorised as a member of a group to be in possession of the drug or preparation and the drug or preparation is to be supplied or procured in accordance with the provisions of these Regulations, and, in the case of a person licensed or authorised as a member of a group, with the terms and conditions of his license or group authority:
Provided that for the purposes of this sub-regulation the administration of a drug or preparation—
(a) by or under the direct supervision, and in the presence, of a medical practitioner;
(b) by or under the direct personal supervision, and in the presence, of a dental surgeon;
(c) by a nurse in charge of a ward, theatre, or outpatients department, in a hospital;
(d) by a midwife under, and, in accordance with regulation 16;
(e) by a person authorised as a member of a group to supply that drug or preparation acting under or in accordance with the terms and conditions of his group authority;
shall not be deemed to be the supplying of the drug or preparation.
13. Possession of drugs and preparations
(1) A person shall not be in possession of a drug or preparation, unless he is generally so authorised or, under this regulation, so licensed or authorised as a member of a group, nor otherwise than in accordance with the provisions of these Regulations and, in the case of a person licensed or authorised as a member of a group, with the terms and conditions of his license or group authority.
(2) For the purposes of these Regulations—
(a) a person to whom a drug or preparation is lawfully supplied by a medical practitioner or veterinary surgeon;
(b) a person to whom a drug or preparation is lawfully supplied on a prescription given by a medical practitioner, a dental surgeon, or veterinary surgeon;
(c) a person to whom a drug or preparation is lawfully supplied by an authorised seller of poisons;
shall be deemed to be a person generally authorised to be in possession of the drug or preparation so supplied:
Provided that a person supplied with a drug or preparation by, or on a prescription given by, a medical practitioner shall be deemed not to be a person generally authorised to be in possession of the drug or preparation if—
(i) he was then being supplied with a drug or preparation by, or on a prescription given by, another medical practitioner in the course of treatment, and did not disclose the fact to the first mentioned medical practitioner before obtaining the supply from that practitioner or on the said practitioner's prescription; or
(ii) he or any other person on his behalf made a declaration or statement for the purpose of obtaining the supply or prescription, and the declaration or statement was false in any particular.
14. General authority for certain classes of persons to possess and supply drugs and preparations
(1) Subject to the provisions of these Regulations, a person who is a member of any of the following classes, that is to say—
(a) medical practitioners;
(b) dental surgeons;
(c) veterinary surgeons;
(d) pharmacists who are employed or engaged at a hospital, clinic, dispensary, or like institution, administered by the Government or by a local authority or in any other hospital, clinic, dispensary, or like institution approved by the Minister, or in any Government medical store;
(e) a nurse in charge of a ward, theatre, or outpatients department, in a hospital;
(f) a person in charge of a laboratory used for the purposes of research or instruction and attached to—
(i) the University of Zambia or other educational institution, or such a hospital as aforesaid approved for the purposes of this regulation by the Minister; or
(ii) any hospital referred to in paragraph (d);
(g) Government analyst; or
(h) persons appointed as inspectors under the Act;
shall be authorised, so far as may be necessary for the practice or exercise of his said profession, function, or employment, and in his capacity as a member of his said class, to be in possession of, and to supply, drugs and preparations:
Provided that nothing in this sub-regulation shall—
(i) authorise a dental surgeon to supply drugs or preparations unless the drugs or preparations are administered by him, or under his direct supervision and in his presence, to persons receiving treatment by him; or
(ii) authorise a nurse in charge of a ward, theatre, or outpatients department, in a hospital—
(a) to procure a drug or preparation, except from a person employed or engaged in dispensing medicines at the hospital or infirmary, and except upon a written order therefor signed by her; or
(b) to supply a drug or preparation, except in accordance with the directions of a medical practitioner in charge of any patients in the ward, theatre or outpatients department, as the case may be.
(2) A written order, signed by a nurse to which paragraph A of proviso (ii) to sub-regulation (1) relates, shall be marked in such a way as to show that it has been fulfilled, by the person employed or engaged in dispensing medicines who fulfils that order, and be kept in the dispensary, and a copy of the order, shall be kept by the nurse in charge of that hospital department, for which the drug or preparation to which the order relates was procured.
(3) The matron of any hospital referred to in paragraph (d) of sub-regulation (1), in which no pharmacist is employed or engaged in dispensing medicines, is authorised in her capacity as a matron and so far as is necessary for the purposes of that hospital and the exercise of her duties, to procure drugs and preparations on the order, in writing, of a medical practitioner employed or engaged in that hospital, and to be in possession of, and to supply, drugs and preparations so procured.
(4) Every drug or preparation in the actual custody of a person authorised by virtue of this regulation, or procure, administer, possess, or supply the said drug or preparation, shall, except when the necessities of the practice of the profession, function, or employment, by virtue of which that person is authorised as aforesaid, otherwise require, be kept in a locked receptacle which can be opened only by him or by some other person authorised by virtue of this regulation, to be in possession of that drug or preparation.
15. Special provisions in respect of certain public officers, etc.
(1) The Permanent Secretary may at his discretion license —
(a) any Government officer in charge of a station at which no Government medical officer is stationed, or from which a Government medical officer is for the time being absent;
(b) any Government officer who undertakes a journey on duty during which he will be more than twenty-four hours distance from any Government station;
(c) any person in charge of a mission station of a missionary society;
(d) a police officer in charge of a police station; or
(e) a first-aid worker in the employ of any mining company;
to procure, possess, and administer, drugs and preparations, subject to the provisions of sub-regulation (2) and such terms and conditions as the Permanent Secretary may fix.
(2) The following provisions shall apply to the supply to, and the possession, and administration by, a person licensed in terms of sub-regulation (1), that is to say—
(a) on each occasion that he procures a drug or preparation, he shall, in addition to a signed order referred to in regulation 24, produce his license to the supplier;
(b) on each occasion that he procures a drug or preparation he shall enter in a drugs register to be kept by him and used solely for the purpose of this sub-regulation, the name and the amount of the drug or preparation, the form in which it is procured, the date, and the name and address of the supplier;
(c) he shall, when he administers a drug or preparation, as soon as practicable thereafter, enter in his drugs register the name of the drug or preparation administered, the name and address of the person to whom it was administered, the amount administered, and the form in which it was administered.
(d) he shall, except when a drug or preparation, is to be administered, kept every drug or preparation in his custody, in a locked receptacle which can be opened only by him or another licensed person; and
(e) he shall not administer a drug or preparation procured in terms of this regulation otherwise than for strictly medical purposes.
16. Special provisions in respect of midwives
(1) In this regulation, the expression “midwive's supply order” means an order in the form prescribed in the first Schedule to these Regulations, specifying the name of the midwife obtaining a supply of the drug or preparation, stating the fact that she is a midwife and giving the following particulars in regard to the drug or preparation to be procured, that is to say, its name, the purpose for which it is required and the total quantity to be procured, or, when the drug or preparation is packed in ampoules, either the said total quantity or the total quantity intended to be administered or injected.
(2) A midwife is hereby authorised, so far as is necessary for the practice of her profession or employment as a midwife, to be in possession of tincture of opium and pethidine, which she has procured upon furnishing to the supplier thereof a midwive's supply order, and to administer those drugs or preparations.
(3) An application for a midwive's supply order shall be made in writing to the Permanent Secretary.
(4) A midwive's supply order will be valid until the thirty-first day of December in the year it is issued.
(5) The following provisions shall apply to the supply to a midwife, and the possession and administration by a midwife, of drugs or preparations, that is to say—
(a) on each occasion a midwife procures a drug or preparation she shall, in addition to a signed order referred to in regulation 24, produce her midwive's supply order;
(b) the supplier shall note on the midwive's supply order the date on which the drugs or preparations are supplied, the name and quantity of the drugs or preparations supplied, and his name and address;
(c) on each occasion a midwife procures a drug or preparation she shall enter in a drugs register, to be kept by her and used solely for the purpose of this regulation, the name and amount of the drug or preparation, the form in which it is procured, the date, and the name and address of the supplier;
(d) a midwife shall, when she administers a drug or preparation or as soon as practicable thereafter, enter in the drugs register the name of the drug or preparation administered, the amount administered, and the form in which it is administered;
(e) a midwife shall not in any one year procure a quantity of a drug or preparation greater than the total amount of that drug or preparation specified in her midwive's supply order; and
(f) a midwife shall, except when the necessities of the practice of her profession or employment as a midwife otherwise require, keep every drug in her possession in a locked receptacle which can be opened only by her.
17. Special provisions in respect of operators of aircraft
(1) In this regulation—
“aircraft” means any aircraft in which passengers are carried for hire or reward;
“Air Navigation Regulations” means the Air Navigation Regulations made under the Aviation Act or any Act amending or replacing the same;
“Director of Civil Aviation” has the meaning assigned to it in the Air Navigation Regulations;
“operator” means any person who is the owner or operator of any aircraft;
“passengers carried for hire or reward” has the meaning assigned to it in the Air Navigation Regulations.
(2) Subject to the provisions of sub-regulation (8) all operator is authorised to procure and possess drugs and preparations, for the purposes of regulation 34 of the Air Navigation Regulations (which relates to first-aid equipment).
(3) The following provisions shall apply to the supply to, and the possession by, an operator, of drugs and preparations, that is to say—
(a) an order referred to in regulation 24, for the supply of drugs and preparations, shall be made in duplicate on the official note paper of the operator, and shall be signed and dated by the operator or his authorised representative;
(b) it shall be stated in the order whether the order is for the initial supply or for replacement of any drugs or preparations previously supplied in terms of this regulation and, if for replacement, the reason therefor;
(c) the order shall be countersigned by the Director of Civil Aviation, who shall send the duplicate to the Permanent Secretary;
{mprestriction ids="2,3,5"}
(d) drugs and preparations shall be in single dose ampoule-syringe form or in the form of an ampoule with a sterile disposable syringe needle and an ampoule file, and shall be kept in a sealed container adequately labelled to indicate the method of use and the quantity and nature of the contents and kept in the first-aid kit of the aircraft;
(e) the quantity of drugs and preparations carried in any aircraft shall not amount to more than the equivalent of 15 mg of morphine for each person who may lawfully be on board that aircraft at any one- time;
(f) a responsible official appointed by the operator shall—
(i) satisfy himself at intervals not exceeding one month, that the drugs and preparations carried in each aircraft have not been removed from the first-aid kit for any unauthorised purpose;
(ii) inspect and check at intervals not exceeding six months, the drugs and preparations carried in each aircraft;
(g) the operator shall keep a permanent record, at his principal place of business in Zambia, of the receipt, distribution, and disposal, of all drugs and preparations obtained in terms of this regulation;
(h) drugs and preparations procured by an operator in terms of this regulation shall not be transferred, on the change of ownership of any of his aircraft, to another person without the permission of the Permanent Secretary.
(4) Any person who ceases to be an operator shall—
(a) notify the Permanent Secretary of the fact; and
(b) dispose of the drugs and preparations in his possession in accordance with the directions of the Permanent Secretary.
[ Am by SI 50 of 1976.]
18. General authority for authorised sellers of poisons to manufacture preparations and to retail drugs and preparations
(1) An authorised seller of poisons shall be authorised—
(a) in the ordinary course of his retail business, to manufacture at any premises registered under section 15 of the Pharmacy and Poisons Act—
(i) any extract or tincture of cannabis; and
(ii) any preparation;
(b) subject to the provisions of these Regulations, to carry on at any such premises the business of retailing, dispensing, and compounding, drugs and preparations; and
(c) to supply drugs and preparations otherwise than by way of wholesale dealing:
Provided that nothing in this regulation shall be construed as authorising any such person to be in possession of any drug or preparation except on premises registered under the said section 16.
(2) Every drug or preparation, other than a preparation for the time being specified in Part I of the Schedule to the Act, in the actual custody of a person authorised by virtue of this regulation to be in possession thereof, shall be kept in a locked receptacle which can be opened only by him or by some assistant of his who is a registered pharmacist and is not a person whose authority has been withdrawn under regulation 29.
(1) In this regulation the expression “recognised preparation” means a preparation contained in the British Pharmacopoeia, the British Pharmaceutical Codex, or the British National Formulary a publication issued jointly by the British Medical Association and the Pharmaceutical Society of Great Britain and used, for the purposes of those Regulations, to serve the usual requirements of persons prescribing preparations whether in hospitals or in general practice.
(2) The following provisions shall apply to prescriptions prescribing a drug or preparation, that is to say—
(a) a prescription shall be in writing and shall be signed by the person giving it, with his usual signature, and dated by him;
(b) a prescription shall be written in ink or otherwise so as to be indelible;
(c) a prescription shall specify the name and address of the person for whose treatment it is given or, if it is given by a veterinary surgeon, the name and address of the person to whom the drug or preparation prescribed is to be delivered;
(d) a prescription shall have written thereon, if given by a dental surgeon, the words “for local dental treatment only” and, if given by a registered veterinary surgeon, the words “for animal treatment only”;
(e) if the preparation prescribed is a recognised preparation, or if all the preparations contained therein are recognised preparations, specify the total amount of the preparation or, as the case may be, of each preparation or, when the preparation is packed in ampoules, either specify as aforesaid or specify the total amount of the preparation or, as the case may be, of each preparation intended to be administered or injected;
(f) if the preparation prescribed is not a recognised preparation, specify the total amount of the drug to be supplied or, when the preparation is packed in ampoules, either the said total amount or the total amount intended to be administered or injected; and
(g) in the case of a cancellation, obliteration, or alteration in a prescription, each cancellation, obliteration, or alteration shall be signed by the person giving it with his usual signature.
(2) In the case of a prescription given for the treatment of a patient in a hospital, sub-regulation (1) shall be deemed to have been complied with if the prescription is written on a patient's bed-card or case- sheet, and in such a case the initials of the person giving the prescription shall be deemed to be a sufficient signature for the purposes of this regulation.
20. Provisions as to supply on prescription
(1) A person shall not supply a drug or preparation on a prescription—
(a) unless the Prescription complies with the provisions of these Regulations relating to prescriptions;
(b) unless, he either is acquainted with the signature of the person by whom it purports to be given and has no reason to suppose that it is not genuine, or has taken reasonably sufficient steps to satisfy himself that it is genuine;
(c) before the date specified in the prescription.
(2) If a prescription prescribing a drug or preparation expressly states that it may, subject to the lapse of an interval or intervals specified by the prescriber in the prescription, be dispensed a second or third time, the drug or preparation thereby prescribed may, as the case may be, be supplied a second or third time after the specified interval or intervals but not more; but, subject as aforesaid, a prescription shall not for the purposes of these Regulations be taken as enabling the drug or preparation prescribed to be supplied more than once.
(3) A person dispensing a prescription prescribing a drug or preparation shall, at the time of dispensing it, mark thereon the date on which it is dispensed and, in the case of a prescription which may be dispensed a second or third time, the date of each occasion on which it is dispensed, and shall retain and keep it on the promises where it is dispensed and so as to be at all times available for inspection.
(4) No person shall make or supply a copy of any prescription prescribing a drug or preparation, other than a copy of a prescription for submission to the Government or a medical aid society for the purpose of receiving payment for such a drug or preparation supplied thereon, unless he is requested to do so by the Permanent Secretary, an inspector, a police officer of the rank of sub-Inspector or above, or any other police officer authorised in writing by a magistrate or by a police officer of the rank of sub- Inspector or above, and such copy of a prescription shall be clearly and indelibly marked “Copy only, Not to be dispensed”.
(5) Notwithstanding anything contained in these Regulations, where an authorised seller of poisons is reasonably satisfied that a person ordering any drug or preparation is a medical practitioner who is by reason of some emergency unable to furnish a prescription immediately, he may, notwithstanding that no prescription has been given, if the said person undertakes to furnish him, within seven days next following, with a prescription, deliver the drug or preparation ordered in accordance with the directions of the said person, so however, that notwithstanding anything in the said directions, the supply shall not be repeated unless a prescription has been given.
(6) If any person by whom an undertaking, referred to in sub-regulation (5) has been given, fails to deliver to the seller a prescription in accordance with the undertaking, or if any person, for the purpose of obtaining delivery of any drug or preparation under the provisions of this regulation, makes a statement which is to his knowledge false, he shall be deemed to have contravened the provisions of sub-regulation (5).
21. Report of cases to Permanent Secretary
Any medical practitioner who considers it necessary, for the purpose of the treatment by him of any patient, to prescribe a drug or preparation for a period exceeding four months, shall report the case to the Permanent Secretary.
(1) Save as otherwise provided in this regulation no medical practitioner shall supply or administer to, or prescribe for, any person, a drug or preparation merely for the purpose of addiction.
(2) A medical practitioner who considers it necessary, for the purpose of the treatment or care of a patient who is a drug addict, that he should receive rational supplies of a drug or preparation, shall report the case to the Permanent Secretary.
(3) When a case is reported in terms of sub-regulation (2), the Permanent Secretary may at his discretion permit, in writing, a medical practitioner to supply, and additionally or alternatively administer, and additionally or alternatively prescribe, such quantities of the drug or preparation to which the patient is addicted as the Permanent Secretary may in the circumstances consider necessary.
(4) No medical practitioner shall supply or prescribe, for the treatment of a drug addict, a drug or preparation in excess of the quantity permitted by the Permanent Secretary.
(5) No person generally authorised, licensed, or authorised as a member of a group to have in his possession a drug or preparation, shall use that drug or preparation by way of self-administration, otherwise than in accordance with these Regulations.
23. Markings of packages and bottles
(1) Subject to the provisions of this regulation, no person shall—
(a) supply a drug unless the package or bottle in which it is contained is plainly marked with the amount of the drug contained therein; or
(b) supply a preparation unless the package or bottle in which it is contained is plainly marked—
(i) in the case of a powder, solution, or ointment, with the total amount thereof in the package or bottle, and the percentage of the drug contained in the powder, solution, or ointment; or
(ii) in the case of cachets, single dose injections, lozenges, suppositories, pills, tablets, or other similar articles, with the amount of the drug in each article, and the number of articles in the package or bottle.
(2) Nothing in this regulation shall apply in a case where a drug or preparation is lawfully supplied in accordance with this Part, by, or on a prescription lawfully given by, a medical practitioner.
24. Production of order in writing to supplier
A person generally authorised, licensed, or authorised as a member of a group, shall not procure a drug or preparation unless he produces to the supplier an order in writing signed and dated by him, in which it is stated—
(a) the name and address of the person by whom the drug or preparation is required, or the institution for which it is ordered;
(b) the name and quantity of the drug or preparation required; and
(c) the name and address and profession or qualification of the person signing the order.
(1) Every person generally authorised, licensed or authorised as a member of a group, to supply drugs or preparations, other than a preparation for the time being specified in Part I of the Schedule to the Act, except a nurse who is generally so authorised by virtue of regulation 14(1) (e), shall comply with the following provisions, that is to say—
(a) he shall, in accordance with the provisions of this regulation and of regulation 32, keep a register and enter therein, in chronological sequence in the form specified in the Second Schedule to these Regulations, true particulars with respect to every quantity of any drug or preparation obtained by him, and with respect to every quantity of any drug or preparation supplied by him, whether to persons within or outside Zambia;
(b) he shall use a separate register or separate part of the register for entries made with respect to each of the substances for the time being specified in paragraph 1 of the Schedule to the Act, or in paragraphs 2, 3, 4, 5, 6, or 7 thereof; and for this purpose each substance shall be deemed to comprise its salts and any preparation, admixture, extract, or other substance containing any proportion of it or its salts, and any isomer of a substance the existence of which is possible within its specific chemical designation, shall be deemed to be identical with that substance.
(2) Notwithstanding the provisions of sub-regulation (1)—
(a) a separate section within a register, or a separate part of a register, may be used with respect to different drugs, preparations, or strengths of preparations, comprised within the class of drugs or preparations to which that register or separate part of a register relates;
(b) so much of sub-regulation (1) as requires a person to enter in the register required to be kept under that sub-regulation, particulars with respect to drugs or preparations supplied by him, shall not apply to a medical practitioner if he enters in a book in which he records patient's case histories, hereinafter called “the day book”, true particulars of every drug or preparation supplied by him to any person, together with the name and address of that person, and the date of the supply, and enters in a separate book kept for the purposes of this regulation, a proper reference to each entry in the day book which relates to the supply of any drug or preparation, and if paragraphs (c) and (d) of this sub- regulation are complied with;
(c) references in the said separate book shall be made in chronological sequence, and the book shall be kept in separate parts relating respectively to the several classes of drugs and preparations specified in, and under, paragraph (b) of sub-regulation (1), and shall not be used for any purpose other than the purposes of this sub-regulation;
(d) the entries in the day book, and in the separate book, shall be made on the day on which, but for this sub-regulation, an entry would under regulation 32 have been required to be made in the said register, and paragraph (c) of regulation 32 shall apply as respects any such entry as aforesaid as if it were an entry in the register;
(e) in this sub-regulation, the expression “a proper reference” means a reference which is entered in the said separate book under the same date as that on which the entry in the said day book or in the Pharmacy Act book was made, and is otherwise such as to enable that entry to be easily identified.
(3) Where a medical practitioner, dental surgeon or veterinary surgeon obtains, or supplies, any drug or preparation packed in ampoules he shall be deemed to have complied with the requirements—
(a) of sub-regulation (1), in regard to entry in the register required to be kept under the said sub- regulation, of true particulars with respect to every quantity of every drug or preparation obtained or supplied; or
(b) in the case of a medical practitioner supplying drugs or preparations to any person, of sub- regulation (2), in regard to entry in the day book referred to in sub-regulation (2), of particulars of any drug or preparation supplied by him;
if he enters the amount which he has obtained or supplied, as the case may be, or true particulars as to either the total quantity of the drug or preparation, or the total quantity thereof intended to be administered or injected.
(4) Every separate book kept under sub-regulation (2), every day book in which any entry is made under sub-regulation (2), and every Pharmacy Act book containing an entry which is referred to in such a separate book as aforesaid, shall be kept on the premises to which the register or book relates and, in the case of a book referring to a prescription, shall be kept on the premises on which the prescription was dispensed so as to be at all times available for inspection.
(5) For the purposes of the preceding sub-regulations, a drug or preparation administered by, or under the direct supervision and in the presence of, a medical practitioner, or dental surgeon shall be deemed not to have been supplied by him.
(6) A manufacturer of any preparation for the time being specified in Part I of the Schedule to the Act, and a wholesale dealer in any such preparation, shall keep every invoice or other like record issued in respect of each quantity of any such preparation obtained by him, and in respect of each quantity of any such preparation supplied by him.
(7) A retail dealer in any preparation, for the time being specified in Part I of the Schedule to the Act, shall keep every invoice or other like record issued in respect of each quantity of any such preparation obtained by him.
(8) Notwithstanding the provisions of paragraph (a) of sub-regulation (1), an authorised seller of poisons may use drugs or preparations for the dispensing of medicines containing such amount of drugs and preparations as is sufficient to make the medicine a drug to which Part III of the Act applies, but only if the transaction and the date of the transaction are recorded in his register.
PART IV
GENERAL
In this Part of these Regulations, the expression “drug” means a drug to which Part II of these Regulations or a substance to which Part III of these Regulations applies.
27. Definition of “possession”
For the purposes of these Regulations, a person shall be deemed to be in possession of a drug, if it is in his actual custody, or is held, by some other person subject to his control, for him or on his behalf.
28. Supply otherwise than on prescription
(1) Where a drug other than a substance specified in Part I of the Schedule to the Act, is to be lawfully supplied to any person (hereinafter in this regulation referred to as “the recipient”), otherwise than by, or on a prescription given by, a medical practitioner, the person supplying the drug (hereinafter in this regulation referred to as “the supplier”) shall not deliver it to the person who purports to be sent by, or on behalf of the recipient, unless that person either—
(a) is generally authorised, licensed, or authorised as a member of a group, to be in possession of that drug; or
(b) produces to the supplier a statement in writing signed by the recipient to the effect that he is empowered by the recipient to receive the drug in question on behalf of the recipient, and the supplier is reasonably satisfied that the document is a genuine document.
(2) A person to whom a drug is lawfully delivered in the circumstances mentioned in sub-regulation (1), shall be deemed to be a person authorised to be in possession thereof, but for such period only, as in the circumstances of the case, is reasonably sufficient to enable delivery to the recipient to be effected.
(1) Where any person generally authorised—
(a) is or has been convicted of an offence against the Act, or these Regulations, or of attempting to commit any such offence or of soliciting, inciting, aiding or abetting, any other person to commit any such offence;
(b) is adjudged, certified, or otherwise lawfully proved to be mentally disordered or defective under any law relating to mental disorders;
(c) is undergoing treatment as a temporary or voluntary patient in terms of any law referred to in paragraph (b) above; or
(d) is proved, to the satisfaction of the Minister, to have become a drug addict;
the Minister may, if he is of the opinion that that person cannot properly be allowed to remain a person generally authorised, by notice in the Gazette, withdraw the authority of that person.
(2) Where the general authority of any person has been withdrawn under these Regulations, the Minister may at any time restore it, or may suspend the withdrawal and, while the withdrawal is so suspended, the person shall be a person generally authorised in the same manner as if the authority had never been withdrawn, so however, that the Minister may at any time cancel the suspension.
30. Consignment between places outside Zambia
(1) If any drugs permitted under the law of any country outside Zambia to be exported therefrom to any destination outside Zambia, are brought into Zambia, no person shall cause or procure those drugs to be diverted to any other destination, unless he is licensed under this regulation by the Permanent Secretary and otherwise than in accordance with the terms and conditions of his license .
(2) For the purposes of this regulation the destination to which any drugs are permitted to be exported shall be taken to be the destination stated in the permission for the export thereof from the country of export.
31. Revocation or amendment of license of group authority
The Minister may revoke or amend, at any time, a license or group authority given under these Regulations.
32. Requirements as to registers
The following requirements shall be complied with by any person required to keep a register under, as the case may be, regulation 9 or 25, that is to say—
(a) the class of drugs to which the entries on any page of any such register as aforesaid, relate, shall be specified at the head of that page;
(b) every entry required to be made, under the said regulations 9 and 25, in the register shall be made on the day on which the drug is received or, as the case may be, on which the transaction with respect to the supplying of the drug by the person required to make the entry takes place; but if that is not reasonably practicable, on the day next following the said day;
(c) no cancellation, obliteration, or alteration of any entry shall be made, and every correction of an entry shall be made only by way of a marginal note or footnote which shall specify the date on which the correction is made;
(d) every entry required to be made as aforesaid in every register, and every correction of an entry, shall be made in ink or otherwise so as to be indelible;
(e) a register shall not be used for any purpose other than the purposes of these Regulations;
(f) the person required, as aforesaid, to keep a register shall, on demand made by the Permanent Secretary or by any person empowered in writing by the Permanent Secretary in that behalf—
(i) furnish such particulars as may be required with respect to the obtaining or supplying by him of any drug, or with respect to any stock of drugs in his possession;
(ii) for the purpose of confirming any such particulars as aforesaid, produce any stock of drugs in his possession; and
(iii) produce the register and such other books or documents in his possession, relating to any dealings in drugs as may be required;
(g) a separate register shall be kept in respect of each set of premises at which the person required to keep the register carries on business; but save as aforesaid not more than one register shall be kept at one time, in respect of each class of drug for which he is required to keep a separate register or part of a register, so however, that a separate register may, with the approval of the Permanent Secretary, be kept in respect of each department of the business carried on by him;
(h) every such register shall be kept at the premises to which it relates, so as to be at all times available for inspection.
(1) All registers, records, books, prescriptions, orders in writing, and other documents which are kept, issued, or made in pursuance of the requirements, or for the purposes of these Regulations, shall be preserved, in the case of a register, book, or other like record for a period of two years from the date on which the last entry therein is made, and in the case of any other document, for a period of two years from the date on which it is issued or made.
(2) In the case of any document kept in pursuance of sub-regulations (6) and (7) of regulation 25, the keeping of a copy thereof made at any time during the said period of two years, shall be treated for the purposes of sub-regulation (1) as if it were the keeping of the original document.
34. Exception of police officers and carriers
Nothing in these Regulations as respects the possession of a drug shall apply to—
(a) a police officer acting in the course of his duty as such; or
(b) a person carrying on the business of a carrier, or to any servant of such a person, acting in the course of that business.
35. Exemption of certain classes of agents
For the purposes of these Regulations, a person shall not be treated as procuring or offering to procure a drug for any person by reason only that he, in the course of his business as agent for another, offers for transfer, or acts in the transfer of, a business and stock-in-trade therewith which comprises a drug.
36. Requirements in respect of cessation of practice, etc.
(1) Any person lawfully in possession of drugs shall, before ceasing to practice or exercise his profession, function, or employment, at any place—
(a) where he is being succeeded by a person generally authorised, authorised as a member of a group, or a licensed person—
(i) physically check with, and hand over to his successor all drugs in his possession;
(ii) submit to the Permanent Secretary a statement signed by himself and by his successor, certifying that the said drugs have been physically checked and handed over in accordance with sub- paragraph (i);
(iii) after handing over the drugs, rule off each page of the register on which an entry has been made, and both he and his successor shall, when satisfied that it is a true record of the drugs on hand, sign each page; and
(iv) if either person is not satisfied that any entry referred to in sub-paragraph (iii) is a true record, he shall refuse to sign the page and shall immediately inform the Permanent Secretary of the reason for his refusal;
(b) where he is not being succeeded by a person generally authorised, authorised as a member of a group, or a licensed person—
(i) inform the Permanent Secretary of the arrangements he has made for the disposal of the drugs in his possession; and
(ii) immediately after disposing of the drugs in accordance with those arrangements or an Order made under sub-regulation (2), as the case may be, he shall notify the Permanent Secretary that he has done so and shall, at the same time, forward the register and the supporting prescriptions and written orders to the Permanent Secretary who shall retain them for a period of two years from the latest date of entry.
(2) Where the arrangements referred to in paragraph (b) of sub-regulation (1) have not been made or are not to the satisfaction of the Permanent Secretary, the drugs shall be disposed of in such manner as the Permanent Secretary shall order.
37. Construction of license or authority
For the purposes of these Regulations, but subject in each case to the express terms of the regulation by which he is generally authorised or, as the case may be, to any limitation attached to his license , or group authority—
(a) a person generally authorised or licensed to manufacture a drug shall be deemed to be generally authorised or, as the case may be, licensed to supply that drug;
(b) a person generally authorised, licensed, or authorised as a member of a group, to supply a drug, shall be deemed to be generally authorised or, as the case may be, licensed or authorised as a member of a group to be in possession of, to procure, to offer to supply or procure, and to advertise for sale, that drug.
(1) No person shall in the course of supplying a drug to a person in Zambia consign that drug, by road or rail, by a route which entails the carriage of that drug beyond the borders of Zambia, unless he is in possession of a movement license issued by the Permanent Secretary for the purposes of this regulation.
(2) The holder of a movement license shall—
(a) in the case of a drug which is to be supplied in one package, place the duplicate of his movement license inside the outer wrapper of that package; or
(b) in the case of a drug which is to be supplied in more than one package—
(i) place the duplicate of his movement license inside the outer wrapper of one package;
(ii) consecutively number on the outer wrapper all the packages in which the drug is contained; and
(iii) indicate on each package the number of the package in which the duplicate of his movement license is to be found.
39. Form of application for license
Application for a license under the Act or for a license or permit under these Regulations shall be—
(a) made in such form as the Permanent Secretary may determine;
(b) accompanied, if the application is for a license to export any drug from Zambia, by the original copy of the certificate of the country of importation officially approving the import of that drug; and
(c) accompanied by the appropriate fee, if any, prescribed in the Third Schedule.
40. Revocation of GN 59 of 1956 and savings
(1) The Dangerous Drugs Regulations, 1956, are hereby revoked.
(2) Nothing in sub-regulation (1) shall render invalid any license , authority, certificate or order, issued, granted or given, or other -thing done, under the Dangerous Drugs Act, 1955, or the Regulations revoked by these Regulations, and any such license , authority, certificate, order, or other thing which could have been issued, granted or given or other thing done, under any provision in these Regulations, and which is in force at the date when these Regulations come into operation, shall be deemed to have been issued, granted or given, or done, under that provision.
(3) Any register, record, book, prescription, or other document, which is required to be kept under any regulation revoked by these Regulations, shall be kept in the same manner and for the same period, and every person shall be subject to the same requirements in regard thereto, as if these Regulations had not been made.
THE DANGEROUS DRUGS REGULATIONS, 1971
[Regulation 16]
MIDWIVES' SUPPLY ORDER
I hereby certify that .............................................................................................................................
of .........................................................................................................................................................
is a practising midwife and is authorised in pursuance of sub-regulation (2) of regulation 16 of the Dangerous Drugs Regulations, to procure during the period of validity of this supply order and for the purpose of her profession, tincture of opium, and pethidine preparations not exceeding the quantities stated below.
............................................................................................................................................................
............................................................................................................................................................
This supply order shall remain valid until the 31st December of the year in which it is issued, and shall be returned to me immediately on becoming invalid.
| Place…………………………………. | Signed………………………………………. Permanent Secretary Date of Issue……………………………. MIDWIVES' SUPPLY ORDER (To be printed on the reverse) (1) This supply order shall be produced to the person from whom the drugs are procured. (2) The supplier shall at the time the transaction takes place, note under the appropriate heading in this order the date on which the drugs are supplied, the name and quantity of the drugs supplied, and his name and registered address. PETHIDINE PREPARATIONS
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